RP-HPLC Method Development and Validation for Determination of Sorafenib in Bulk Drug Substance and Pharmaceutical Dosage Forms

A simple, rapid, precise, and accurate, reversed phase high performance liquid chromatographic method was developed and validated for determination of Sorafenib (SORA) in the tablet dosage form.The chromatographic separation was achieved on Grace 4.6 (id) x 250 mm column at detector wavelength of 263 nm, using a mobile phase consisting of acetonitrile and methanol in a ratio of 45:55 v/vat a flow rate 1.0/ml.The retention time for Sorafenib (SORA) was found to be 3.821.The method showed adequate precision with a relative standard deviation (RSD) smaller than 2%.The accuracy was analyzed by adding a standard drug and good recovery values were obtained for all drug concentrations used.The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for the quantification of Sorafenib (SORA) in the tablet dosage form.The analytical procedure is reliable and thus, the developed RP-HPLC method can be successfully feasible for the routine quality control analysis of SORA in a pharmaceutical dosage form.